Evaluation of Professional Practices in the Treatment of Refractory Idiopathic Overactive Bladder at the Dose of 50 Units (TOX50IUU) (TOX50IUU)

Evaluation of Professional Practices in Botulinum Toxin Type A Intradetrusor Injection, at the Dose of 50 Units for the Treatment of Urinary Incontinence by Refractory Idiopathic Overactive Bladder

Considering that the 2013 Hermieu's guidelines differs from the product marketing authorization delivered in November 2014, the primary endpoints is to evaluate life quality by questionnaires at the baseline time, and after two, six and twelve weeks of treatment in patients suffer from urinary incontinence by refractory idiopathic overactive bladder and treated by Botox® at the dose of 50UI (international units)

Study Overview

• Status: Unknown
• Conditions: Bladder, Overactive
• Intervention / Treatment: Drug: OnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-States

Detailed Description

Currently, Botox injection is one of the second-line treatments for urinary incontinence by idiopathic overactive bladder. Multiple studies have shown that Botox at the dose of 50UI is effective but not for a long time. Maximum efficiency is about two weeks and until about twelve weeks compared to the dose between 100UI and 300UI that shown an efficiency until twenty-four at thirty-six weeks. But it's not without consequence since the side effects are more numerous increasing the dose. The most frequent are urinary retention with necessary to perform clean intermittent catheterization and urinary infection.

This dose at 50UI is therefore more a test to assess the patient's tolerance to the product, as recommended by the product marketing authorization.

So, through this evaluation of professional practices, investigators would like to evaluate the patient satisfaction treated in hospital, with a first dose at 50UI.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU de Clermont-Ferrand
    • Principal Investigator: Sandrine CAMPAGNE-LOISEAU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female ≥ 18 yo, suffers from urinary incontinence by idiopathic overactive bladder, inadequately treated by 2 anticholinergic medicines during a period of 3 months for each of them or stopped for intolerance or adverse events

Description

Inclusion Criteria:

• Female
• Age ≥ 18 yo
• Refractory idiopathic overactive bladder
• Eligibility to an injection treatment
• Capacity to perform clean intermittent catheterization

Exclusion Criteria:

• Protected adults (under trusteeship, guardianship or judicial protection)
• Patients under anticholinergics for an other desease (psychiatric, neurologic for example)
• Known hypersensitivity or at risk of hypersensitivity to botulinum toxin type A like myasthenic syndrom
• Patients who suffer from an overactive bladder with a known cause (neurological, urological condition)
• urinary infection under treatment < 48 hours before Botox® injections
• Suspicious looking bladder requiring biopsies during the cystoscopy
• Pregnant or breastfeeding women
• Language barriers

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
female with urinary incontinence; Female ≥ 18 years, suffers from urinary incontinence by idiopathic overactive bladder, inadequately treated by 2 anticholinergic medicines during a period of 3 months for each of them or stopped for intolerance or adverse events	Drug: OnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-States; Botox® intradetrusor injections, with a rigid cystoscope, under local anaesthesia performed by Lidocaïne 2% diluted in 30ml of bicarbonate 14‰. 20 injections of 0,5ml each will be heterogeneously administrated into the bladder wall, sparing the trigone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the life quality by the KHQ (King's Health Questionnaire)	Patients will have to answer the questionnaire at home depending the symptoms that they feel at 6 weeks. The data will then be collected by phone	Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire	Patients will have to answer the questionnaires at home depending the symptoms that they feel. The data will then be collected by phone. The data will then be collected and analysed.	Week 2
Evaluation of the life quality by the USP (Urinary Symptom Profile) questionnaire	Patients will have to answer the questionnaires at home depending the symptoms that they feel. The data will then be collected during the postoperative consultation. The data will then be collected and analysed.	Week 12
Evaluation of the life quality by the KHQ (King's Health Questionnaire)	Patients will have to answer the questionnaires at home depending the symptoms that they feel. The data will then be collected by phone at 2 weeks. The data will then be collected and analysed	Week 2
Evaluation of the life quality by the KHQ (King's Health Questionnaire)	Patients will have to answer the questionnaires at home depending the symptoms that they feel. The data will then be collected during the postoperative consultation. The data will then be collected and analysed	Week 12
Patient experience's evaluation of the local anaesthesia and outpatient care thanks to the EVAN-LR (Evaluation du Vécu de l'ANesthésie Loco-Régionale) questionnaire	Patients will have to answer the questionnaire before the return home just after the injection session to assess their experience concerning local anaesthesia and outpatient management.	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Sandrine CAMPAGNE-LOISEAU, PH, CHU de Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: August 30, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Botox; idiopathic overactive bladder; Onabotulinum toxinA; 50 units
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: RNI 2019 CAMPAGNE-LOISEAU; 2019-A01296-51 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No